External Glaucoma Drainage Device

DESCRIPTION (provided by applicant): Glaucoma is one of the leading causes of blindness in the world affecting 67 million people. Reduction of intraocular pressure (IOP) is the only proven treatment for delaying the progression of vision loss caused by glaucoma. The current surgical options for IOP lowering are unpredictable and suboptimal in terms of success rate. One of the primary reasons for surgical failure is the wound healing around the glaucoma drainage device (GDD) outflow path. To circumvent manyof the problems with existing procedures, we propose a novel GDD that drains aqueous humor externally; and thereby, avoids fibrous capsule formation over the outlet end of the device. In addition to increasing predictability, the surgical time will be significantly reduced. Currently, there is no GDD on the market that drains aqueous humor to the external ocular surface. The objectives of the proposed project are to finalize the design of the resistive component of the GDD and to test the safety and efficacy of the GDD to reduce IOP in an animal model. Our novel GDD which drains aqueous humor to the external ocular surface will effectively lower IOP without increasing the risk of infection. Specific Aim 1 is to test the flow characteristics of GDD and the prevention of bacterial migration. The study will investigate variations in the resistive mechanism of the GDD in vitro using perfusion techniques. The experimental data will be analyzed to determine the pressure set by the GDD at simulated aqueous production rates. Additionally, Pseudomonas aeruginosa and Staphylococcus aureus inoculation will test the permeability of the GDD and its resistance to biofilm formation. Specific Aim 2 is to investigate the efficacy of the GDD in vivo t lower IOP and prevent infection over a two month follow-up period. Our long-term goals are to investigate the feasibility draining aqueous humor to the external ocular surface and to develop a novel GDD that can predictably lower IOP without an increased risk of infection. Camras Vision, Inc. will collaborate with experts from the Surgery, Biomedical Engineering and Ophthalmology Departments at Duke University. Camras Vision was founded by Duke-affiliated entrepreneurs, was runner-up for healthcare in the 2011 Duke Start-up Challenge and has already attracted the interests of a large pharmaceutical firm, which may transition into a strategic partnership to fund future research and development. The comprehensive approach we propose for this Phase I grant will set the stage for long-term animal testing in glaucoma models and a first-in-man study in Phase II. PUBLIC HEALTH RELEVANCE: Vision loss from glaucoma is an increasing public health problem to millions of people. Current treatments cannot effectively reduce and maintain an acceptable level of eye pressure to halt damage to the optic nerves. This project proposes to develop and to test the safety and efficacy of a new technology that may halt vision loss with a unique design that can safely and predictably lower intraocularpressure (IOP).